Ammonia N 13

Product NDC
52670-552
11-digit product format
526700552
Labeler code
52670
Product ID
52670-552_46dfe34a-40c9-373e-e063-6294a90af7cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ammonia n-13
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mayo Clinic
Application
ANDA203321
Marketing category
ANDA
Marketing start
2013-02-25
Substance
AMMONIA N-13
Active strength
37.5 mCi/mL
Pharmacologic classes
Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ammonia N 13
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMMONIA N-1337.5 mCi/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9OQO0E343Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b8eb56be-edf0-4b39-8ab1-e48c4aa676efProduct name520220126
76ba8fa2-294c-406c-aab2-68cb80b6d1aaProduct name920210511
612e700f-023c-452e-a2e6-3ea15fd646dbProduct name120190416

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52670-552-30Ammonia N 1330 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMMONIA N-13ACTIVE INGREDIENT9OQO0E343ZAMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [MAYO CLINIC]7
AMMONIA N-13ACTIVE MOIETY9OQO0E343ZAMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [MAYO CLINIC]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XAMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [MAYO CLINIC]7
WATERINACTIVE INGREDIENT059QF0KO0RAMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [MAYO CLINIC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52670-552AMMONIA N 13 (AMMONIA N-13) INJECTION, SOLUTION [MAYO CLINIC]13Current NDC, Legacy NDC, 1 package rows20241219_af70d0da-1c2d-44e4-b4cd-7cce6636c7b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52670-552-305267005523030 mL in 1 VIAL, SINGLE-DOSE (52670-552-30) 30 ml2013-02-250000-00-00NoNoCurrent